1. Technical Field
The present disclosure relates generally to medical devices, systems, and their methods of use. In particular, the present disclosure relates to devices and systems for penetrating thrombus or other occlusive material within a body lumen, and their corresponding methods of use.
2. The Technology
The process of thrombosis may produce a fibrinous blood clot or thrombus in a patient's vasculature. Thrombus may occasionally be harmlessly dissolved in the blood stream. At other times, however, thrombus may lodge in a blood vessel or embolize to a distal blood vessel where the thrombus can partially or completely occlude the flow of blood. If the partially or completely occluded vessel provides blood to a sensitive tissue such as the brain or heart serious tissue damage or death may result. In the United States and Europe thrombosis is a leading cause of disabling diseases and death.
The occurrence and presence of thrombus can occur in several ways. Thrombus can occur in coronary procedures where thrombus is associated with myocardial infarction or heart attack. The use of vascular filters, grafts, and/or stents can also produce thrombus. Furthermore, the progression of peripheral artery disease itself can form thrombus. Venous thrombus can result from trauma, vessel injury, immobilization (i.e., bed rest), cancer, advanced age, and/or hypercoagulable blood chemistry. Thrombus can also form in arteries and other body lumens. For example, as an artery becomes blocked with atherosclerotic material, thrombus can result as blood passes through the restricted diseased artery. Finally, interventional procedures themselves can create thrombus.
Over time, thrombus can become chronic or mature, attaching to a body lumen wall and/or stiffening such that mechanical removal of the thrombus or treatment of the thrombus with thrombolytic medications becomes unacceptably difficult and/or impossible. Accordingly, treatment of chronic or mature thrombus often requires recanalization to form a new or larger flow path between the distal and proximal ends of the thrombus in order to relieve back pressure and/or restore circulation of blood or other bodily fluids within the body lumen. However, currently available systems notoriously have difficulty recanalizing chronic or mature thrombus, are difficult to use, and involve lengthy procedures.